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Behavioral Intervention

Heat Therapy for Prediabetes (HEAT Trial)

N/A

Waitlist Available

Led By Hui-Ying Luk, PhD; Danielle Levitt, PhD

Research Sponsored by Hui Ying Luk

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 60 years

Body weight ≥ 110 pounds

Must not have

History of peripheral neuropathies

Medical complications that could contraindicate participation in the high intensity interval training (HIIT) intervention including: orthopedic complications that would limit the ability of the participant to perform cycling exercise, significant cardiovascular impairments (e.g., history of arrhythmias, severe uncontrolled hypertension, etc.), diagnosed metabolic disease (e.g., diabetes), renal disease, and cancer in remission for <6 months.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up before intervention, after phase 1 (at about 12 weeks), and after phase 2 (at about 24 weeks, except hiit group)

Summary

This trial aims to determine if using heat pads on the legs can improve muscle health, physical function, and blood sugar control in older individuals with prediabetes as effectively as High-Intensity Interval Training (

Who is the study for?

The HEAT trial is for older individuals who have prediabetes. It's designed to see if applying heat pads to the legs can improve muscle health and blood sugar control, similar to high-intensity exercise.

What is being tested?

This study tests whether leg heat therapy can match or boost the benefits of High-Intensity Interval Training (HIIT) on muscle structure, glucose tolerance, and frailty in older adults with prediabetes.

What are the potential side effects?

Potential side effects may include discomfort or skin irritation from the heat pads and typical exercise-related risks like muscle soreness or strain from HIIT.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 60 years old or older.

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I weigh at least 110 pounds.

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My blood sugar levels indicate I have prediabetes.

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I am not on any medication that could affect the study's treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of nerve damage in my hands or feet.

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I don't have health issues that would stop me from doing intense cycling exercises.

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I am currently on prescription blood thinners.

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I have more than 1.5 inches of fat over my muscle.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before intervention, after phase 1 (at about 12 weeks), and after phase 2 (at about 24 weeks, except hiit group)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before intervention, after phase 1 (at about 12 weeks), and after phase 2 (at about 24 weeks, except hiit group)

This trial's timeline: 3 weeks for screening, Varies for treatment, and before intervention, after phase 1 (at about 12 weeks), and after phase 2 (at about 24 weeks, except hiit group) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Exercise capacity

Frailty status

Glycemic control

+2 more

Secondary study objectives

Anthropometrics 1

Anthropometrics 2

Body composition

+1 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Local Heat TherapyExperimental Treatment2 Interventions

Phase 1: Heat pads will be applied to both legs and set to a pre-determined, optimized temperature to raise the intramuscular temperature to \~40°C. Each heating session will last for 90 min/d, 7d/wk (6 at-home and 1 in-lab) for 12 wks. Phase 2: High-intensity interval training will be performed 3 d/wk for 12 wks. Each exercise session will consist of 4 cycling exercise intervals at 90-95% HRpeak for 4 min with 3 min active rest.

Group II: High-Intensity Interval TrainingActive Control1 Intervention

Phase 1: High-intensity interval training will be performed 3 d/wk for 12 wks. Each exercise session will consist of 4 cycling exercise intervals at 90-95% HRpeak for 4 min with 3 min active rest. Phase 2: N/A

Group III: Thermoneutral TherapyPlacebo Group2 Interventions

Phase 1: Heat pads will be applied to both legs and set to a pre-determined temperature to keep the intramuscular temperature in a thermoneutral state (\~35-37°C). Each heating session will last for 90 min, 7d/wk (6 at-home and 1 in-lab) for 12 weeks. Phase 2: High-intensity interval training will be performed 3 d/wk for 12 wks. Each exercise session will consist of 4 cycling exercise intervals at 90-95% HRpeak for 4 min with 3 min active rest.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Heat therapy

2013

N/A

~300

High-intensity interval training

2016

Completed Phase 4

~1160